Company · US
AMO Manufacturing USA, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2023. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
17recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 12, 2023 | K223838 | Catalys™ Precision Laser System Amo Manufacturing USA, LLC | OOE |
| May 17, 2022 | K220516 | CATALYS Precision Laser system Amo Manufacturing USA, LLC | OOE |
| Apr 7, 2021 | K210701 | CATALYS Precision Laser System Amo Manufacturing USA, LLC | OOE |
| Nov 9, 2018 | K182083 | Catalys Precision Laser System Amo Manufacturing USA, LLC | OOE |
| Aug 25, 2017 | K172002 | Catalys Precision Laser System Amo Manufacturing USA, LLC | OOE |
| Jan 6, 2015 | K141852 | IFS ADVANCED FEMTOSECOND LASER SYSTEM Amo Manufacturing USA, LLC | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2021 | AMO Manufacturing USA, LLC Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System No Bed, Models: 0160-6020 (United States), 0160-6010 Open, Classified |
OOE | K113479 |
| Oct 21, 2021 | AMO Manufacturing USA, LLC iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301 Open, Classified |
LZS | None listed |
| Nov 4, 2011 | AMO Manufacturing USA, LLC Abbott brand Advanced Femtosecond Laser Systems, Model iFS, Catalog Number: J20007D/J/K;
Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA
Product Usage: Intended Terminated |
HNO | K031960 |
| Nov 4, 2011 | AMO Manufacturing USA, LLC Abbott brand IntraLase Femtosecond Laser System, Model 3; Catalog Numbers: 20004D/J/K, R20004J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA
Product Usage: Terminated |
HNO | K031960 |
| Nov 4, 2011 | AMO Manufacturing USA, LLC Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20003D/J/K, 20005D/J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA
Pr Terminated |
HNO | K031960 |
| Aug 9, 2011 | AMO Manufacturing USA, LLC STAR S4 IR Excimer Laser System; Software Version 5.30
Mfg by : AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
Iris registration is designed to compensate for pupil centroid shi Terminated |
LZS | None listed |
| Aug 9, 2011 | AMO Manufacturing USA, LLC STAR S4 IR Excimer Laser System; Software Version 5.22
Mfg by : AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
Iris registration is designed to compensate for pupil centroid shi Terminated |
LZS | None listed |
| Aug 9, 2011 | AMO Manufacturing USA, LLC STAR S4 IR Excimer Laser System; Software Version 5.21
Mfg by : AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
Iris registration is designed to compensate for pupil centroid shi Terminated |
LZS | None listed |
| Aug 9, 2011 | AMO Manufacturing USA, LLC STAR S4 IR Excimer Laser System; Software Version 5.20
Mfg by : AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
Iris registration is designed to compensate for pupil centroid shi Terminated |
LZS | None listed |
| Aug 9, 2011 | AMO Manufacturing USA, LLC STAR S4 IR Excimer Laser System; Software Version 5.18
Mfg by : AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
Iris registration is designed to compensate for pupil centroid shi Terminated |
LZS | None listed |
| Aug 9, 2011 | AMO Manufacturing USA, LLC STAR S4 IR Excimer Laser System; Software Version 5.16
Mfg by : AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
Iris registration is designed to compensate for pupil centroid shi Terminated |
LZS | None listed |
| Aug 9, 2011 | AMO Manufacturing USA, LLC STAR S4 IR Excimer Laser System; Software Version 5.15
Mfg by : AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
Iris registration is designed to compensate for pupil centroid shi Terminated |
LZS | None listed |
| Aug 9, 2011 | AMO Manufacturing USA, LLC STAR S4 IR Excimer Laser System; Software Version 5.10
Mfg by : AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
Iris registration is designed to compensate for pupil centroid shi Terminated |
LZS | None listed |
| Aug 9, 2011 | AMO Manufacturing USA, LLC STAR S4 IR Excimer Laser System; Software Version 5.02
Mfg by : AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
Iris registration is designed to compensate for pupil centroid shi Terminated |
LZS | None listed |
| Aug 9, 2011 | AMO Manufacturing USA, LLC STAR S4 IR Excimer Laser System; Software Version 5.01
Mfg by : AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
Iris registration is designed to compensate for pupil centroid shi Terminated |
LZS | None listed |
| Aug 9, 2011 | AMO Manufacturing USA, LLC STAR S4 IR Excimer Laser System; Software Version 5.00
Mfg by : AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
Iris registration is designed to compensate for pupil centroid shi Terminated |
LZS | None listed |
| Feb 18, 2011 | AMO Manufacturing USA, LLC AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67,
Part Number: 0070-1531, Catalog Numbers:
0070-1664,0070-1649,0070-1654: Version 3.67
0070-1721: Version 3.671
0070-1662: Ver Terminated |
LZS | None listed |